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Atorvastatin in Relapsing-Remitting Multiple Sclerosis

This study has been completed.
Sponsor:
Collaborators:
German Research Foundation
German Federal Ministry of Education and Research
Pfizer
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT00616187
First received: February 5, 2008
Last updated: February 14, 2008
Last verified: February 2008
History of Changes

February 5, 2008
February 14, 2008
October 2003
June 2007   (final data collection date for primary outcome measure)
number of MRI contrast enhancing lesions [ Time Frame: treatment months 6 to 9 compared to baseline ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00616187 on ClinicalTrials.gov Archive Site
other MRI-based parameters (CEL volume, T2-lesion load, T1-hypointense lesion volume, whole brain magnetization transfer ratio, and apparent diffusion coefficient of normal appearing white matter) [ Time Frame: treatment months 6 to 9 compared to baseline ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Atorvastatin in Relapsing-Remitting Multiple Sclerosis
Oral High-Dose Atorvastatin Treatment in Relapsing-Remitting Multiple Sclerosis

A phase II open-label baseline-to-treatment trial was designed to evaluate the safety, tolerability and efficacy of orally administered atorvastatin in patients with relapsing-remitting multiple sclerosis (RRMS). Patients with at least one gadolinium-enhancing lesion (CEL) at screening by magnetic resonance imaging (MRI) were eligible for the study. Patients are screened and enrolled in the outpatient clinic of the Cecilie Vogt Clinic at the Charité - University Medicine Berlin. After a baseline period of 3 monthly MRI scans (months -2 to 0), patients followed a 9-month treatment period on 80 mg atorvastatin daily. The primary endpoint is the number of CEL in treatment months 6 to 9 compared to baseline. Secondary endpoints include other MRI-based parameters and changes in clinical scores and immune responses.
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Relapsing Remitting Multiple Sclerosis
  • Drug: interferon beta treatment to add-on atorvastatin treatment
    IFN-β-1a 22 µg s.c. 3 times weekly or IFN-β-1b s.c. every other day (3 months baseline) and add on oral daily 80 mg atorvastatin (9 months add on treatment)
  • Drug: untreated to atorvastatin treatment
    no treatment(3 months baseline)and oral daily 80 mg atorvastatin (9 months add on treatment)
  • Active Comparator: interferon
    Intervention: Drug: interferon beta treatment to add-on atorvastatin treatment
  • Sham Comparator: untreated
    Intervention: Drug: untreated to atorvastatin treatment
Paul F, Waiczies S, Wuerfel J, Bellmann-Strobl J, Dörr J, Waiczies H, Haertle M, Wernecke KD, Volk HD, Aktas O, Zipp F. Oral high-dose atorvastatin treatment in relapsing-remitting multiple sclerosis. PLoS ONE. 2008 Apr 9;3(4):e1928.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
41
Not Provided
June 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 18 - 55 years old
  • MS diagnosis according McDonald criteria
  • Relapsing-remitting MS
  • EDSS 0 - 6
  • Disease activity as occurrence of CEL in brain MRI
  • IFN-beta therapy for at least 6 months

Exclusion Criteria:

  • Primary chronic progressive MS
  • Symptoms and signs of clinical disease conditions similar to MS
  • Conditions that can disturb MRI measurements
  • Clinically relevant GI diseases eg Colitis ulcerosa, Crohns disease, history of Ulcus pepticum
  • Clinically relevant lung, heart, CNS, infectious disease
  • Clinically relevant liver, kidney or bone marrow abnormalities (as defined by specific clinical chemistry values)
  • Allergies towards Gd-DTPA
  • Allergies towards constituents of the therapeutic agent
  • Recruitment to other clinical trials within 6 months prior to or during this study
  • Pretreatment with complete lymph irradiation, antibody therapy against lymphocyte populations (eg. anti-CD4, Campath-1H), mitoxantrone, cyclophosphamide, cyclosporin A, human antibodies, all immunomodulatory or immunosuppressive agents including recombinant cytokines or other potential experimental MS therapies (6 months prior to study start), glatiramer acetate, azathioprine, IVIg (6 months prior to study start) pregnancy or lactation
  • Alcohol or drug abuse
  • Inhibitors of Cytochrom P 450 3A (eg. cyclosporin, macrolide antibiotics, azole antimycotics).
  • Medical or psychological conditions that could hamper with the patients capacity to understand patient information, to give the informed consent, to adhere to the protocol of the study and to be able to complete the study
Both
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00616187
1931/Si.270 am 8.5.03, ATV-D-03-007G
Yes
Professor Frauke Zipp, Cecilie Vogt Clinic for Neurology, Charite University, Berlin, Germany
Charite University, Berlin, Germany
  • German Research Foundation
  • German Federal Ministry of Education and Research
  • Pfizer
Principal Investigator: Frauke Zipp, MD Cecilie Vogt Clinic for Neurology, Charite, Berlin
Charite University, Berlin, Germany
February 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP